Cancer of the Liver, Liver Cancer, Neoplasms, Liver
Conditions
Brief summary
This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.
Detailed description
This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System. The data gathered from participating sites will be available to be analyzed to develop ablation parameter guidance for ablation approaches under varying patient liver tissue conditions and liver lesions. This is an "umbrella registry," which was included as an optional component in other NEUWAVE studies; hence, data from consenting patients who are or will be enrolled in other NEUWAVE soft tissue liver lesion ablation studies will be included in this registry. All other patients will be enrolled and followed prospectively, enrolled retrospectively with prospective, longitudinal follow up, or enrolled retrospectively with all retrospective follow up. Enrollment for this study will include up to 1,500 patients throughout the world who underwent or are scheduled to undergo microwave ablation of one or more soft tissue liver lesions using the NEUWAVE Microwave Ablation System or the NEUWAVE Microwave Ablation System with Ablation Confirmation.
Interventions
DEVICEMicrowave Ablation
Patients who meet the eligibility criteria will undergo microwave ablation (MWA) with the NEUWAVE Microwave Ablation System with or without Ablation Confirmation of at least one soft-tissue liver lesion, in accordance with the study site's standard-of-care (SOC) practices.
Sponsors
Ethicon, Inc.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who underwent or are scheduled to undergo a microwave ablation of one or more liver lesions with the NEUWAVE Microwave Ablation System per the device's Instructions for Use (IFU). 2. Patients with signed informed consent (or waiver approved by IRB/EC) who are willing to comply with the assessment schedule, and willing to have data included in the database. 3. Patients greater than or equal to 22 years old at the time of informed consent (or waiver approved by IRB/EC).
Exclusion criteria
1. Patients with a life expectancy of less than 1 year, in the opinion of the treating physician. 2. Use of microwave ablation purely as a transection tool, rather than focused liver lesion ablation. 3. Patient is currently participating, or planning to participate, in another NeuWave/Ethicon-funded clinical trial or registry studying microwave ablation in the liver. Note: roll-over patients from previous NeuWave trials are permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Whose Ablation Resulted in Technical Success | Immediately post-ablation (Day 0) | Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as defined by the performing physician who will make the assessment using CT, MRI, PET, US, and/or X-ray, immediately following the procedure. |
| Number of Patients Whose Ablation Resulted in Technique Efficacy | Between 7 days and less than 3 months post-ablation | Technique efficacy is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as defined by the performing physician who will make the assessment using CT, MRI, PET, US, and/or X-ray at Visit 3 (between 7 days and less than 3 months post-ablation). |
| Target Lesion Recurrence Rate | Assessed at 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, and 60 months post-ablation. | Target lesion recurrence (local recurrence) was evaluated at every visit after ablation of the target lesion(s) and assessed by CT, MRI, PET, US, and/or X-ray. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Assessed at 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, and 60 months post-ablation. | Overall survival was evaluated at every visit after ablation of the target lesion(s) |
Countries
China, France, Germany, Netherlands, Singapore, South Korea, United Kingdom, United States
Participant flow
Recruitment details
1254 participants enrolled in the study. 1 participant withdrew from the study, 1 participant discontinued, and 49 of these participants were later screen failures as they did not meet all inclusion/exclusion criteria. 1203 participants were treated with the NeuWave microwave ablation device.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.4 Years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 76 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 929 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 198 Participants |
| Number of Target Lesions per Participant 1 Lesion | 970 Participants |
| Number of Target Lesions per Participant 2 Lesions | 158 Participants |
| Number of Target Lesions per Participant 3 Lesions | 55 Participants |
| Number of Target Lesions per Participant 4 Lesions | 12 Participants |
| Number of Target Lesions per Participant 5 or More Lesions | 8 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Asian | 238 Participants |
| Race/Ethnicity, Customized Black or African American | 34 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Not Reported | 141 Participants |
| Race/Ethnicity, Customized Other | 32 Participants |
| Race/Ethnicity, Customized White | 751 Participants |
| Sex: Female, Male Female | 376 Participants |
| Sex: Female, Male Male | 827 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 213 / 1,203 |
| other Total, other adverse events | 398 / 1,203 |
| serious Total, serious adverse events | 488 / 1,203 |
Outcome results
None listed